The Effect of Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction With and Without Suture Tape Reinforcement

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05270551
Collaborator
(none)
114
2
14

Study Details

Study Description

Brief Summary

The aim of our study is to evaluate the effect of accelerated rehabilitation post ACL reconstruction with and without augmentation on graft healing and return to normal activity clinically by scoring system and radiologically.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ACL Reconstruction
N/A

Detailed Description

ACL reconstruction is the most commonly performed knee ligament reconstruction and employs a variety of surgical techniques. However, despite high success rates, it is still challenged by residual laxity and graft rupture.

While the majority of patients who undergo ACLR will have good to excellent results, a subset of patients is at a higher risk for graft failure. For those that require revision surgery, the second operation often fails. Anterior cruciate ligament injuries account for 50% of knee ligament injuries for high school-aged adults.

The most commonly used autografts for ACLR are the hamstring tendons (HT) and the bone-patellar tendon-bone (BPTB). However, questions remain about how patients with either an HT or a BPTB autograft recover knee muscle strength postoperatively.

To help address and prevent future ACL failures, new repair and reconstruction techniques have been employed that incorporate suture augmentation. The goal of augmentation is to protect the newly repaired or reconstructed ligament during rehabilitation.

Despite advances in anterior cruciate ligament (ACL) reconstruction surgical techniques and rehabilitation, recent studies report that between 20% to 50% of those with ACL reconstruction do not return to the same sports after surgery and 10% to 70% of those who resume preinjury sports participate at a reduced level or with significant functional impairments.

Anecdotal evidence from patient report and clinical observation suggests that an inability to return to sports after ACL reconstruction can be partially attributed to a fear of reinjuring the knee.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
The Effect of Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction With and Without Suture Tape Reinforcement
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1

Without augmentation

Procedure: ACL Reconstruction
All participants will do ACL reconstruction with and without Augmentation and will receive Accelerated rehabilitation program

Active Comparator: Group 2

With augmentation

Procedure: ACL Reconstruction
All participants will do ACL reconstruction with and without Augmentation and will receive Accelerated rehabilitation program

Outcome Measures

Primary Outcome Measures

  1. Clinical outcome [1 year follow up]

    Tegner Lysholm scores, which assesses activity levels

  2. Clinical outcome [1 year follow up]

    International Knee Documentation Committee (IKDC) scores which assesses symptoms and function in daily living activities

Secondary Outcome Measures

  1. Radiological outcome [6 months follow up]

    Magnetic resonance imaging (MRI) to assess graft healing, ACL tear and graft loosening

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age from 15 to 50 years old.

  • With or without meniscal injury.

  • Isolated ACL injury without any other ligament injury.

  • Recent and chronic injury.

Exclusion Criteria:
  • Multiligament injury.

  • Deformed knee (Genu varus or valgus).

  • Previous ACL reconstruction or repair.

  • Older than 50 years old and younger than 15 years old.

  • Failed ACL reconstruction or repair -

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Mohamed Abdel Hamid, Professor, Mohamad Mohamed Abdel-Hamid Morsy
  • Principal Investigator: Hatem Galal El-Din Zaki, Professor, Hatem Galal El-Din Zaki
  • Study Director: Mohamed Abd El-Radi, Lecturer, Mohamed Abd El-Radi Abd El-Salam

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Abdel-Tawab, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05270551
Other Study ID Numbers:
  • ACL Recon. rehabilitation
First Posted:
Mar 8, 2022
Last Update Posted:
Mar 8, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Abdel-Tawab, Principal Investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022